BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 4830045 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-06315
    Event Type
    Injury
    Date Received
    June 10, 2015
    Report Date
    March 20, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO EXHIBIT LOW AND DECREASING IMPEDANCE, HIGH AND UNSTABLE THRESHOLD WITH SUSPECTED INSULATION DAMAGE. THE RIGHT VENTRICULAR (RV) LEAD IS PLANNED FOR EXTRACTION AND REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379330 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4003M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R RESR01 IPG